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Serious Game for Parkinson's Disease Patients (PARKGAME)

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ClinicalTrials.gov Identifier: NCT02469350
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.

Condition or disease Intervention/treatment
Parkinson's Disease Other: Serious game

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
Actual Study Start Date : June 2015
Primary Completion Date : May 4, 2017
Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Rehabilitation with serious game
18 rehabilitation sessions with serious game during a 6-8 weeks period
Other: Serious game
Rehabilitation with serious game


Outcome Measures

Primary Outcome Measures :
  1. Feasibility questionnaire [ Time Frame: once a week ]
    self-assessment questionnaire


Secondary Outcome Measures :
  1. Acceptability questionnaire [ Time Frame: once a week ]
    self-assessment questionnaire

  2. biomechanical parameters of gait and balance [ Time Frame: at inclusion, 3 weeks, 6 weeks and 18 weeks ]
    recordings of centres of foot and mass displacements and velocities

  3. kinematics parameters of gait and balance [ Time Frame: at inclusion, 3 weeks, 6 weeks and 18 weeks ]
    range of motion of hip, knee and ankle angles


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson's disease
  • Gait and balance disorders
  • Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year).

Exclusion Criteria:

  • Dementia
  • Ongoing severe medical condition that prevented assessments
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469350


Locations
France
ICM, CIC Neurosciences
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Marie-Laure Welter, MD, PhD GHPS, APHP, Paris
More Information

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02469350     History of Changes
Other Study ID Numbers: C15-12
RCB ( Registry Identifier: 2015-A00277-42 )
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Gait and balance disorders
serious game

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases